Amantadine as Adjunctive Therapy to Antipsychotics in Sch... | NCT00999505

Studies
Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia

NCT00999505

Sponsor

Hospital de Clinicas de Porto Alegre

Status

Unknown status

Last Update Posted

Feb 16, 2011Estimated

Enrollment

40Estimated

Phase

Phase 3

Conditions

Schizophrenia

Interventions

Amantadine
Placebo

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
09-303

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Sep 2011Estimated

Completion Date

Sep 2011Estimated

First Submitted Date

Oct 20, 2009

First Submission Date that Met QC Criteria

Oct 20, 2009

First Posted Date

Oct 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2011

Last Update Posted Date

Feb 16, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Amantadine as add-on therapy to antipsychotics may improve schizophrenia positive, negative and cognitive symptoms.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Amantadine	Active Comparator	Amantadine 200mg twice a day	Drug: Amantadine
Placebo	Placebo Comparator	Placebo capsules twice a day	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amantadine	Drug	Amantadine 200mg twice a day over 12 weeks	Amantadine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Scores in Brief Psychiatric Rating Scale		Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Under antipsychotics with residual symptoms

Exclusion Criteria:

Pregnancy
Lactation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clarissa S Gama, MD, PhD	Contact	55-51-33598745		csgama@yahoo.com

Overall Officials

Name	Affiliation	Role
Clarissa S Gama, MD, PhD	Hospital de Clinicas de Porto Alegre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clinicas de Porto Alegre	Recruiting	Porto Alegre	Rio Grande do Sul	90035-903	Brazil

Type	Date	Date Unknown
Release	Aug 17, 2016
Reset	Oct 10, 2016
Release	Feb 22, 2017
Reset	Apr 5, 2017

Submission Tracking

Estimated Results First Submitted Date

Aug 17, 2016

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 17, 2016			Oct 10, 2016
Feb 22, 2017

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000547	Amantadine

Ancestor Terms

ID	Term
D000218	Adamantane
D001952	Bridged-Ring Compounds
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided